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EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke

van der Worp, H. Bart; Macleod, Malcolm R.; Bath, Philip M. W.; Demotes, Jacques; Durand-Zaleski, Isabelle; Gebhardt, Bernd; Gluud, Christian; Kollmar, Rainer; Krieger, Derk W. and Lees, Kennedy R., et al. (2014) In International Journal of Stroke 9(5). p.642-645
Abstract
Rationale Cooling reduced infarct size and improved neurological outcomes in animal studies modeling ischemic stroke, and also improved outcome in randomized clinical trials in patients with hypoxic-ischemic brain injury after cardiac arrest. Cooling awake patients with ischemic stroke has been shown feasible in phase II clinical trials. Primary aim To determine whether systemic cooling to a target body temperature between 34 center dot 0 and 35 center dot 0 degrees C, started within six-hours of symptom onset and maintained for 24h, improves functional outcome at three-months in patients with acute ischemic stroke. Design International, multicenter, phase III, randomized, open-label clinical trial with blinded outcome assessment in 1500... (More)
Rationale Cooling reduced infarct size and improved neurological outcomes in animal studies modeling ischemic stroke, and also improved outcome in randomized clinical trials in patients with hypoxic-ischemic brain injury after cardiac arrest. Cooling awake patients with ischemic stroke has been shown feasible in phase II clinical trials. Primary aim To determine whether systemic cooling to a target body temperature between 34 center dot 0 and 35 center dot 0 degrees C, started within six-hours of symptom onset and maintained for 24h, improves functional outcome at three-months in patients with acute ischemic stroke. Design International, multicenter, phase III, randomized, open-label clinical trial with blinded outcome assessment in 1500 patients aged 18 years or older with acute ischemic stroke and a National Institutes of Health Stroke Scale score of 6 up to and including 18. In patients randomized to hypothermia, cooling to a target body temperature of 34-35 degrees C will be started within six-hours after symptom onset with rapid intravenous infusion of refrigerated normal saline or a surface cooling technique and maintained for 24h with a surface or endovascular technique. Patients randomized to hypothermia will receive pethidine and buspirone to prevent shivering and discomfort. Primary outcome Score on the modified Rankin Scale at 91 days, as analyzed with ordinal logistic regression and expressed as a common odds ratio. Discussion With 750 patients per intervention group, this trial has 90% power to detect 7% absolute improvement at the 5% significance level. The full trial protocol is available at http://www.eurohyp1.eu. ClinicalTrials.gov Identifier: NCT01833312. (Less)
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published
subject
keywords
acute stroke therapy, clinical trial, hypothermia, ischemic stroke, treatment
in
International Journal of Stroke
volume
9
issue
5
pages
642 - 645
publisher
Wiley-Blackwell
external identifiers
  • wos:000337588200022
  • scopus:84902119838
ISSN
1747-4949
DOI
10.1111/ijs.12294
language
English
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yes
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224817c7-20dd-4b80-9111-f0e4d3ae14a6 (old id 4609436)
date added to LUP
2014-09-01 07:41:59
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2017-11-05 03:12:15
@article{224817c7-20dd-4b80-9111-f0e4d3ae14a6,
  abstract     = {Rationale Cooling reduced infarct size and improved neurological outcomes in animal studies modeling ischemic stroke, and also improved outcome in randomized clinical trials in patients with hypoxic-ischemic brain injury after cardiac arrest. Cooling awake patients with ischemic stroke has been shown feasible in phase II clinical trials. Primary aim To determine whether systemic cooling to a target body temperature between 34 center dot 0 and 35 center dot 0 degrees C, started within six-hours of symptom onset and maintained for 24h, improves functional outcome at three-months in patients with acute ischemic stroke. Design International, multicenter, phase III, randomized, open-label clinical trial with blinded outcome assessment in 1500 patients aged 18 years or older with acute ischemic stroke and a National Institutes of Health Stroke Scale score of 6 up to and including 18. In patients randomized to hypothermia, cooling to a target body temperature of 34-35 degrees C will be started within six-hours after symptom onset with rapid intravenous infusion of refrigerated normal saline or a surface cooling technique and maintained for 24h with a surface or endovascular technique. Patients randomized to hypothermia will receive pethidine and buspirone to prevent shivering and discomfort. Primary outcome Score on the modified Rankin Scale at 91 days, as analyzed with ordinal logistic regression and expressed as a common odds ratio. Discussion With 750 patients per intervention group, this trial has 90% power to detect 7% absolute improvement at the 5% significance level. The full trial protocol is available at http://www.eurohyp1.eu. ClinicalTrials.gov Identifier: NCT01833312.},
  author       = {van der Worp, H. Bart and Macleod, Malcolm R. and Bath, Philip M. W. and Demotes, Jacques and Durand-Zaleski, Isabelle and Gebhardt, Bernd and Gluud, Christian and Kollmar, Rainer and Krieger, Derk W. and Lees, Kennedy R. and Molina, Carlos and Montaner, Joan and Roine, Risto O. and Petersson, Jesper and Staykov, Dimitre and Szabo, Istvan and Wardlaw, Joanna M. and Schwab, Stefan},
  issn         = {1747-4949},
  keyword      = {acute stroke therapy,clinical trial,hypothermia,ischemic stroke,treatment},
  language     = {eng},
  number       = {5},
  pages        = {642--645},
  publisher    = {Wiley-Blackwell},
  series       = {International Journal of Stroke},
  title        = {EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke},
  url          = {http://dx.doi.org/10.1111/ijs.12294},
  volume       = {9},
  year         = {2014},
}